JnJ seeks USFDA nod for Tremfya for treatment of plaque psoriasis, juvenile psoriatic arthritis in children
Spring House: Johnson & Johnson has announced the submission of two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA (guselkumab) for the treatment of children 6 years and older with moderate-to-severe plaque psoriasis (PsO) and children 5 years of age and older with active juvenile psoriatic arthritis (jPsA).
The PsO submission is based on data from the Phase 3 PROTOSTAR study in pediatric patients with moderate to severe plaque PsO and bridging pharmacokinetic (PK) data from the Phase 3 VOYAGE 1 and 2 studies in adult patients with moderate to severe plaque PsO. The jPsA submission is based on PK extrapolation analyses from adult PsA studies (DISCOVER 1 and 2) and TREMFYA efficacy and safety data from the PROTOSTAR study.
“This milestone underscores our commitment to transform the standard of care for patients of all ages and builds on our expertise and legacy in IL-23 and immune-mediated diseases,” said Liza O’Dowd, M.D., Vice President, Immunodermatology Disease Area Leader, Johnson & Johnson Innovative Medicine. “There is a critical gap in the treatment of children and adolescents with these skin and joint conditions, where debilitating symptoms can present challenges related to physical appearance and ability to function. At Johnson & Johnson, we are working to address this gap by investigating the efficacy and well-characterized safety profile of TREMFYA for pediatric patients.”
TREMFYA is an approved monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is an important driver of immune-mediated diseases such as plaque PsO and PsA.
Plaque psoriasis (PsO) is an immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful. Almost one-third of PsO cases begin in childhood, with roughly 20,000 children under 10 diagnosed with psoriasis each year. Having visible skin disease can be highly stressful for children and adolescents and can have a long-term impact on those affected.
Juvenile psoriatic arthritis (jPsA) is a form of juvenile idiopathic arthritis (JIA) characterized by chronic joint inflammation, swelling and psoriasis. Juvenile PsA is relatively rare, accounting for approximately 5% of the JIA population. In many cases, the skin manifestations start before the arthritis.
TREMFYA is approved Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis.
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